Conferencia de resultados del 3T 2026 de Akebia (AKBA): demanda de Vafseo, precios y transición a TDAPA

Los resultados del tercer trimestre de 2026 de Akebia Therapeutics (NASDAQ: AKBA) reflejaron un aumento en el uso de Vafseo por parte de los pacientes, aunque los ingresos reportados fueron menores debido a la reducción de inventarios en las clínicas de diálisis. Los ingresos totales cayeron debido a que Auryxia enfrentó competencia de genéricos, mientras que la dirección se centró en la transición de Vafseo en enero de 2027 tras el fin del reembolso bajo TDAPA.

Aspectos clave

• Los ingresos totales disminuyeron a 36,9 millones de dólares desde los 58,8 millones del tercer trimestre de 2025, lo que refleja principalmente la caída en las ventas de Auryxia.
• Los ingresos netos por producto de Vafseo aumentaron un 3% interanual hasta los 14,8 millones de dólares, a pesar de un crecimiento de aproximadamente el 140% en los pacientes bajo tratamiento. La dirección atribuyó esta disparidad a la reducción de inventarios provocada por dosis promedio más bajas y un número de sesiones de diálisis menor de lo previsto.
• La dirección estimó que la demanda subyacente de usuarios finales de Vafseo se situó entre 19 y 20 millones de dólares en el tercer trimestre, frente a los ingresos reportados de 14,8 millones de dólares y una demanda estimada de 17 a 18 millones de dólares en el segundo trimestre.
• Aproximadamente 11.500 pacientes recibían Vafseo, lo que representa alrededor del 20% de los pacientes con anemia tratados por U.S. Renal Care, Dialysis Clinic Inc. e Innovative Renal Care. Cerca del 25% de los pacientes que habían suspendido previamente la terapia la habían reiniciado.
• El ensayo VOICE reportó un 10% menos de hospitalizaciones con vadadustat que con AEE, sin diferencias significativas en la mortalidad. El estudio, realizado con 2.116 pacientes, cumplió sus criterios predefinidos de finalización con un 'win odds' de 1,16 y un valor p de 0,0016.
• El efectivo y equivalentes de efectivo sumaron 159,3 millones de dólares al cierre del trimestre. Akebia señaló que sus recursos, los flujos de ingresos previstos y la refinanciación planificada de su préstamo a plazo deberían financiar su plan operativo actual durante al menos dos años.

Datos financieros principales

Desempeño comercial y operativo

La demanda de Vafseo superó los ingresos reportados

La dirección indicó que su principal cliente asumió inicialmente una dosis promedio de Vafseo de 900 miligramos por tratamiento de diálisis, mientras que el uso real promedió alrededor de 810 miligramos. Los pacientes también asistieron a aproximadamente entre 10,5 y 11 sesiones de diálisis al mes, por debajo de las expectativas de los proveedores de unas 12 sesiones.

Dado que Vafseo se administra mediante dosificación supervisada en algunas clínicas, las sesiones de diálisis perdidas reducen el uso del producto. La menor dosis y la tasa de asistencia inferior generaron un exceso de inventario en las clínicas y redujeron las compras de los clientes durante el tercer trimestre. La dirección estimó que las clínicas redujeron entre 4 y 5 millones de dólares en inventarios durante el trimestre.

Se prevén reducciones adicionales de inventario antes del vencimiento del TDAPA para Vafseo el 1 de enero de 2027, ya que los proveedores evitan mantener productos adquiridos a precios más altos previos al vencimiento.

La estrategia posterior a TDAPA se centra en un acceso más amplio y precios similares a los AEE

Tras el vencimiento de TDAPA, Vafseo pasará a formar parte del pago empaquetado para diálisis y ya no se facturará por separado. La dirección afirmó que esto debería ampliar el acceso más allá de los pacientes elegibles para TDAPA a casi todos los pacientes clínicamente aptos.

Akebia prevé que el costo anual promedio del tratamiento con Vafseo se sitúe entre 1.000 y 1.500 dólares, lo que refleja la caída en los precios de los AEE, una dosificación promedio más baja, la asistencia a diálisis y la fijación de precios basada en volumen. La dirección señaló que tratar al menos entre 200.000 y 250.000 pacientes podría respaldar ingresos máximos de varios cientos de millones de dólares si Vafseo se convierte en el estándar de atención.

DaVita cuenta con un contrato posterior a TDAPA hasta 2027 y solicitó una extensión multianual, según Akebia. La dirección espera que en el cuarto trimestre de 2026 comience un despliegue gradual, seguido de una expansión más significativa a principios de 2027. Fresenius también ha mostrado interés en los datos de VOICE, aunque la dirección prevé que su adopción allí tardará más tiempo.

La evidencia clínica respalda los argumentos para la comercialización

En el estudio VOICE, los eventos adversos graves ajustados por exposición fueron de 121,5 por cada 100 años-paciente para vadadustat, frente a 134,2 para los AEE. Vadadustat también mostró un control de hemoglobina más estable y menos oscilaciones con niveles elevados de hemoglobina en un criterio de valoración exploratorio.

Un análisis económico actualizado de INNO2VATE presentado en la ASN sugirió que Vafseo podría reducir los costos anuales de hospitalización en 6.200 dólares por paciente en comparación con los AEE. Bajo los supuestos del análisis, tratar a todos los pacientes elegibles de diálisis con anemia podría traducirse en más de 600.000 días de hospitalización menos.

Akebia también anunció resultados preliminares positivos del estudio VOCAL. El ensayo realizado en clínicas de DaVita demostró que vadadustat administrado tres veces por semana no fue inferior a la terapia con AEE en el mantenimiento de la hemoglobina. Análisis posteriores evaluarán la estabilidad de la hemoglobina, las transfusiones, la terapia de rescate y las características de los glóbulos rojos.

Avances en la cartera de desarrollo para enfermedades renales raras

Akebia está reclutando pacientes para estudios de Fase II de praliciguat en glomeruloesclerosis focal y segmentaria, y de ebribafusp en un ensayo tipo 'basket' que abarca glomerulopatía C3, nefropatía por IgA y nefritis lúpica. Se esperan los datos iniciales de ebribafusp en 2027.

El ensayo de ebribafusp evaluará principalmente la reducción del cociente proteína/creatinina en orina, la estabilización de la función renal y los biomarcadores del complemento. Akebia tiene como objetivo demostrar actividad a nivel renal sin una inhibición sistémica de la vía alternativa del complemento, lo que la dirección considera un factor diferenciador clave en materia de seguridad.

Perspectivas de la dirección

• La dirección prevé que el número de pacientes de Vafseo siga aumentando en el cuarto trimestre de 2026, impulsado principalmente por U.S. Renal Care, Innovative Renal Care y Dialysis Clinic Inc.
• Los ingresos reportados del cuarto trimestre podrían seguir viéndose afectados por una gestión conservadora de inventarios por parte de los clientes antes del vencimiento de TDAPA.
• Se espera que DaVita inicie un despliegue limitado en el cuarto trimestre, con una expansión más sustancial prevista para principios de 2027.
• Se prevé que los ingresos de Auryxia continúen disminuyendo en comparación con 2025 debido a la competencia de genéricos y a la presión sobre los precios.
• Los datos iniciales del ensayo 'basket' de Fase II de ebribafusp se esperan en 2027. Akebia no proporcionó un cronograma actualizado para los datos de praliciguat.

Riesgos y áreas de atención

• Los ingresos de Vafseo podrían seguir divergiendo del crecimiento en el número de pacientes a medida que los proveedores ajusten el inventario a la dosificación real, la asistencia a diálisis y el fin del reembolso bajo TDAPA.
• La caída de los precios de los AEE ejerce presión sobre el precio de Vafseo posterior a TDAPA, mientras que también se espera que un mayor volumen reduzca el precio promedio.
• La adopción por parte de las grandes organizaciones de diálisis ha sido más lenta de lo que esperaba la dirección. DaVita avanza con cautela, mientras que Fresenius podría requerir más tiempo debido a cambios organizacionales.
• La transición de pacientes desde los AEE hacia Vafseo requiere educación clínica y ejecución operativa en los centros de diálisis.
• Auryxia sigue enfrentando la competencia de genéricos y la presión sobre los precios.
• La perspectiva de financiamiento a dos años señalada por Akebia contempla su plan de refinanciar su línea de préstamo a plazo sénior garantizado.

Aspectos destacados de la sesión de preguntas y respuestas con analistas

Adopción por parte de grandes organizaciones de diálisis: La dirección calificó la solicitud de DaVita de una extensión de contrato multianual como una señal positiva, pero no cuantificó el despliegue previsto. Los médicos que tratan pacientes en organizaciones de diálisis de tamaño mediano coinciden en cerca de un tercio con DaVita y en más del 50% cuando se incluye a Fresenius, lo que podría transferir la experiencia con Vafseo entre proveedores.

Estudio VOCAL y estrategia de dosificación: Akebia todavía está analizando los datos de VOCAL y evaluará cómo los hallazgos podrían respaldar una estrategia regulatoria para la dosificación tres veces por semana. No se proporcionó un cronograma relacionado con la ficha técnica.

Diferenciación de ebribafusp: La empresa busca una reducción de la proteinuria y una función renal estable sin inhibición sistémica de la vía alternativa. Actualmente, ebribafusp se administra una vez por semana mediante inyección subcutánea, aunque la dirección indicó que podría evaluarse una dosificación menos frecuente.

Impacto económico de las hospitalizaciones: La dirección señaló que tasas de hospitalización más bajas podrían beneficiar a las organizaciones de diálisis bajo contratos de atención basados en el valor. Sin embargo, las decisiones de compra siguen siendo muy sensibles al costo de adquisición.

Transcripción completa de la conferencia de resultados

Transcripción completa de la conferencia de resultados

Comentarios de la dirección

Operator

[Operator Instructions] Please be advised that today's conference is being recorded. I would now like to turn the conference over to your first speaker today, Mercedes Carrasco, Senior Director, IR. May we begin?

Mercedes Carrasco

Thank you and welcome to Akebia's third quarter 2026 financial results and business updates conference call. Please note that a press release was issued earlier today, Thursday, November 5th, detailing our third quarter 2026 financial results. And that release is available on the Investor section of our website. For your convenience, a replay of today's call will also be available on our website after we conclude. Joining me for today's call, John Butler, Chief Executive Officer, and Erik Ostrowski, Chief Financial and Chief Business Officer. Dr. Steven Burke, our Chief Medical Officer, and Nicholas Grund, Chief Commercial Officer, are also available for questions. I'd like to remind everyone that this call includes forward-looking statements.

Each forward-looking statement on this call is subject to risks and uncertainties that could cause actual results to differ materially from those described in these statements. Additional information describing these risks is included in the financial results press release that we issued on November 5th, as well as in the Risk Factors and Management's Discussion and Analysis section of our most recent annual and quarterly reports filed with the SEC. With that, I'd like to introduce our CEO, John Butler.

John Butler

Thanks, Mercedes. Good morning, everyone, and thank you for joining us today. Late last month, Akebia joined our peers at ASN Kidney Week in Denver. I left the event with 2 important takeaways. First, I heard tremendous excitement about the VOICE trial data that Dr. Block of U.S. Renal Care presented. We believe the data, which demonstrated a clear and compelling hospitalization outcomes benefit for vadadustat versus an ESA, dosing a regimen that most dialysis providers have chosen to implement, will have dialysis organizations thinking differently about Vafseo, and over time has the potential to drive Vafseo to become standard of care. Second, the spotlight continues to shine on rare kidney disease therapeutic product development, and we're excited about the potential to show meaningful differentiation with our mid-stage pipeline assets across multiple rare kidney indications.

We believe this would represent significant value for our shareholders. Now with this backdrop, let me walk through Q3, starting with our commercial business. We're pleased with the pace at which we're adding patients from the mid-sized dialysis providers, including USRC, DCI, and IRC. Last quarter, the number of patients on Vafseo increased to about 11,500 patients on therapy, representing about 20% of patients treated for anemia within these 3 dialysis organizations. Also important, 25% of patients that had previously discontinued therapy have restarted. Even with this progress, I believe we have significant room to continue driving growth even within the mid-sized dialysis providers, but obviously and especially at the large dialysis organizations. Vafseo net product revenues were $14.8 million for the quarter.

This is only a 3% increase versus the third quarter of last year, despite approximately 140% growth in the number of patients on therapy. There are a few somewhat related factors at play, but it was predominantly a drawdown of inventory based on a lower dose and dialysis compliance rate. If you recall, we told you that we're no longer getting data on average dose at providers who moved to TIW dosing. When our largest customer looked at their utilization, they adjusted their purchases based on the average dose they were seeing versus what they expected. Our customer made their inventory assumptions expecting an average dose of 900 milligrams per dialysis treatment, but the average was about 810 milligrams. Even more impactful, patients have been less compliant with their dialysis sessions than expected. If a patient doesn't show up for dialysis, the patient doesn't receive a Vafseo dose if the unit is using observed dosing. These 2 factors combined meant that there was more inventory in their clinics at the end of last quarter, which impacted their purchases this quarter.

So to make it very clear, when we use the updated dose and compliance data with the number of patients on therapy, end-user demand was between $17 million and $18 million for Q2 and between $19 million and $20 million for Q3. Another takeaway from my conversations at ASN is that while dialysis providers have protocols in place, as individual physicians start using Vafseo in greater numbers, they're using their own strategies to utilize the product and bring patients into or keep patients in the hemoglobin target range. This shouldn't be surprising. It took 20 years for physicians to figure out how to dose ESAs. It's gratifying to see prescribers recognize the benefits of Vafseo for their patients, though it would be easier for us if their approaches were a little more consistent. Our focus is to continue to drive more patients onto therapy and support physicians as they look for the best outcomes for their patients. Beyond the reduction in inventory based on dose and dialysis compliance, as we approach Vafseo's January 1, 2027 TDAPA expiration, expect a continued reduction in inventory levels. No provider wants drug on the shelf that they bought at a higher price when it no longer gets to bill for that price.

Now, we're working proactively to manage this dynamic. To be clear, for Q4, we expect to see continued growth in patients on therapy. That's the most important metric for the long-term growth of the product. On January 1st, we begin our post-TDAPA launch. On that day, Vafseo access will expand beyond the TDAPA-only patients to nearly all clinically eligible patients. Treatment with Vafseo will be reimbursed as part of the dialysis bundle payment, and dialysis organizations will no longer be able to bill separately when they use the product. As we've always said, post-TDAPA, we will price Vafseo to remain competitive with ESA pricing to ensure providers can access an innovative treatment for patients, even within the economic confines of a bundled payment system.

So what does this mean for pricing in 2027 and beyond? Now while we're still working on some of our post-TDAPA contracts, we know ESA price has decreased over time and now incorporating a somewhat lower dose and dialysis compliance, we expect the average annual cost of therapy to fall somewhere between $1,000 and $1,500. Certainly not the price you would normally expect for a product bringing the level of innovation that Vafseo brings, but these are the dynamics of the dialysis market. If we can make Vafseo standard of care, which means ultimately treating at least 200,000 to 250,000 patients, that would mean a potential multi-hundred-million-dollar peak revenue.

So how are we going to get there? As I said, in Q4, even though we expect our customers to be conservative with inventory, we expect to continue to see an increase in patients. We expect Q4 patient growth will be driven primarily by our current mid-sized dialysis providers, USRC, IRC, and DCI. We share our shareholders' desire to see DaVita and Fresenius begin contributing to our revenue. And while we have a post-TDAPA contract with DaVita through 2027, at their request, we're working on a multi-year extension of that contract. And they've outlined their plans to begin rolling out the product slowly, which we expect to start this quarter, and in a much more significant way early next year.

It's clearly been frustrating for us that adoption among the large dialysis providers has not progressed more quickly. But in the end, it's clinical evidence that changes the way prescribers think about patient care. Let me give you a few highlights from the VOICE data presented by Dr. Block at ASN. The trial enrolled 2,116 patients and met the predefined stopping criteria with a win odds of 1.16 and a p-value of 0.0016, establishing non-inferiority and superiority of the primary composite endpoint due to reduction in hospitalizations. The data demonstrated that hospitalizations were 10% lower in patients treated with vadadustat versus ESAs, without a significant difference in mortality rates.

Exposure-adjusted serious adverse events were lower with vadadustat, with 121.5 events per 100 patient-years, compared to 134.2 events per 100 patient-years for patients treated with ESAs. Given that SAEs generally drive hospitalization, this is not a surprising finding. As we've seen in the past, vadadustat showed more stable hemoglobin control versus ESAs. In an exploratory endpoint, the data showed the odds of high hemoglobin excursions were reduced in patients treated with vadadustat compared to ESAs, while there was no overall difference in low excursions. There has never been an outcome study performed before INNO2VATE that compared treatments for patients with anemia due to CKD that demonstrated an outcomes difference. And recall, like the VOICE primary endpoint, the post hoc win statistics analysis of our INNO2VATE study also demonstrated a statistically significant lower risk of dying or being hospitalized for patients receiving vadadustat versus ESAs. Now the health economic analysis of the VOICE hospitalization benefit will be completed, but we presented an updated economic analysis from INNO2VATE at ASN. This analysis suggested that treatment with Vafseo resulted in a $6,200 lower annual cost of hospitalization per patient compared with ESA.

And based on the assumptions used in the analysis, if all eligible dialysis patients with anemia were treated with Vafseo, it could result in more than 600,000 fewer hospital days versus ESA treatment. We have seen and know that adoption in nephrology, particularly dialysis, moves slowly. But this is the data that gives me the confidence to believe that Vafseo will ultimately become standard of care. This morning we announced positive top-line results from the VOCAL study, which we conducted at DaVita clinics. One more study demonstrating vadadustat dosed TIW is non-inferior to ESA in maintaining hemoglobin. We look forward to continuing the analysis of VOCAL to see what further differentiation we may be able to uncover.

Now, ASN was also a great meeting when considering our rare kidney disease pipeline. A significant part of the meeting agenda was dedicated to advances in treating rare kidney diseases. We presented preclinical data that informed our confidence in praliciguat for FSGS, as well as posters on our Phase II trial designs for both ebribafusp and praliciguat. Additionally, Dr. Jim Tumlin presented to a full house in an exhibitor spotlight, focusing on both Prali and Ebri. I was pleased with the interest in both programs from the interactions the team had with investigators and potential investigators. As you know, both programs are enrolling their Phase II trials, Prali in FSGS, and Ebri in a basket trial in C3G, IgAN, and lupus nephritis, with initial data from the Ebri trial expected in 2027.

We're excited about the opportunity for both products, but particularly with Ebri, our tissue-targeted next-generation complement inhibitor. While data will obviously help define our strategy and development priorities, we believe a differentiated approach will allow for strong positioning with the potential for similar efficacy, a potentially better safety profile, and potentially less frequent dosing regimen versus current products in diseases like C3G. We believe there's tremendous value in our pipeline that is underappreciated or ignored in Akebia's value today. Now let me turn it over to Erik to review our third quarter financial results.

John Butler

Thanks, John. Total revenues decreased to $36.9 million in Q3 '26 from $58.8 million in Q3 '25. Turning to the components of these amounts, Vafseo net product revenues increased to $14.8 million in Q3 '26 as compared to $14.3 million in Q3 '25. And Auryxia net product revenues decreased to $20 million in Q3 '26 compared to $42.5 million in Q3 '25. We continue to expect Auryxia revenues to decrease as compared to 2025 due to generic competition and pricing pressure. License, collaboration, and other revenues increased slightly to $2.1 million in Q3 '26 as compared to $2 million in Q3 '25.

Turning to expenses, cost of goods sold was $6.4 million in Q3 '26 compared to $9.4 million in Q3 '25, driven by lower product revenues. R&D expenses increased to $16.2 million in Q3 '26 from $14.9 million in Q3 '25, driven by increased clinical trial activities related to our Phase II trials evaluating Ebri and praliciguat. SG&A expenses decreased to $23.5 million in Q3 '26 from $29.1 million in Q3 '25, driven by lower marketing and headcount-related expenses.

We generated a net loss of $14.4 million in Q3 '26 versus net income of $0.5 million in Q3 '25, driven by this quarter's lower revenues, which was partially offset by lower operating expenses, which included a $1.3 million restructuring charge incurred this quarter. Turning to the balance sheet, we remain in a strong financial position with $159.3 million in cash and cash equivalents at the end of the quarter, which includes $6.6 million in ATM proceeds raised early in the quarter. This compares to cash and cash equivalents of $155.5 million as of June 30, 2026. We believe our existing cash resources and the cash we expect to generate from product, royalty, supply, and license revenues, along with our plan to refinance our senior secured term loan facility, will allow us to continue to invest in the future and enable us to fund our current operating plan for at least the next 2 years. With that, we will now open the line for questions.

Operator

[Operator Instructions] Our first question will come from the line of Julian Harrison of BTIG.

Preguntas y respuestas

Andrew Kassin

Hi, this is Andrew on for Julian. I know you talked a little bit about the status of DaVita and the uptake of Vafseo, but is there any more color you can provide on the potential ramp we could expect at the end of this year and in 2027? And then one on the pipeline, just any updates specifically on the enrollment in the praliciguat trial along with the Ebri trial? Thank you.

John Butler

Thanks, Andrew. So as I mentioned, I mean, we think it's a really positive sign that while DaVita has a post-TDAPA contract for '27, that they requested that we extend that contract out a number of years. To me, that suggests that they're expecting this product to be meaningful in their clinics. And, again, talking to folks from DaVita at the ASN meeting, it really is the VOICE data, that outcomes data, that is really driving that interest. And they've kind of outlined how they see it rolling out. I think their preference is that those kinds of conversations stay confidential. I don't know, Nick, if you want to add any color on our conversations there?

John Butler

Yes, I mean, they've been really constructive conversations around the extension of their contract. My opinion is you wouldn't want to do that unless you were going to make a larger step into Vafseo utilization, locking up that price. ESA-like pricing for a longer period of time allows you to do that because it creates certainty. So that's been, I think, a positive signal overall when we think about their role. And, again, we don't want to talk about anything specific, but their interest in VOICE, and now with VOCAL coming through, remember VOCAL was USRC versus Mircera, whereas VOCAL was Vafseo versus Epogen. This gives them another piece of data for what that conversion may look like within their DaVita population, because they are a Mircera shop overall. And so I take the contract extension as positive. And, you know, certainly having plans for a rollout that they're sharing with us, I think, is positive as well.

John Butler

And I mean, we've talked about the frustration, right? I mean, there's no question we're frustrated that things haven't moved faster. I think the word to use around DaVita is deliberate. They are very deliberate in the way they approach things. And the challenge of that for a company like DaVita is it takes them a long time to get going. The other side of that coin, we hope and count on is that once they start going, they can influence things very quickly in their units, and it becomes very sticky. And our job is to make sure that they have a very good experience as they convert people to Vafseo in their units. And your second question, Andrew, was around enrollment in our rare kidney trials.

And we haven't given any updates on timing for praliciguat. You know, we are, again, we don't want to do that until we feel really confident in getting the trial enrolled. I mean, I think when you look at other trials in FSGS, I think we would suggest that we're enrolling the trial at the same sort of pace. So that's what we would expect, but it's a competitive space and we want to make sure we know exactly when we're going to have the data before we make that announcement. You know, Ebri, of course, is a basket trial, open label. We're super excited about what Ebri can deliver. And we know we'll be able to deliver data sooner out of that trial. But it's early days there, right? But I will say again, seeing the sessions at ASN and having conversations with these kind of KOLs there, the differentiation that we can potentially bring with Ebri really is exciting to the community, and I think it can be a very, very meaningful product.

Andrew Kassin

Thank you for that, really helpful color.

John Butler

Thanks, Andrew.

Operator

And our next question will be coming from the line of Roger Song of Jefferies.

Nabeel Nissar

Hey, good morning. This is Nabeel on for Roger. So, on the VOCAL data, you mentioned some additional data that you're expecting. What could we look at beyond the hemoglobin non-inferiority? What other data could we be expecting here, dose intensity, dose adjustment frequency in VOCAL compared to VOICE? And then with all of this data, do you think we have enough evidence to pursue TIW on the label? Thank you.

John Butler

Thanks, Nabeel. So, you know, VOCAL, we've just presented top-line data. So as you can appreciate, I'm sure, there's many other analyses to be done, including thinking about how that would inform regulatory strategy around TIW. Steve, maybe some of the other kind of the omics and things, talk about that a little bit.

Steven Burke

Sure. This is Steve Burke, CMO. We have endpoints related to measures of hemoglobin stability, so high and low hemoglobin excursion, the need for red blood cell transfusion, rescue therapies. So we don't have that data yet. We also have some exploratory work going around red blood cell phenotyping. So are red blood cells made under the influence of Vafseo substantially different than those made under the influence of ESAs, which would make sense if there would be, given the different mechanism of action. So, we're waiting on data around that, proteomics, metabolomics, lipidomics on the red blood cells. So that could be quite interesting.

John Butler

Thanks, Steve. Nabeel, did that capture what you were looking for on Vafseo?

Nabeel Nissar

Yeah, no, that's very helpful. And then as we're thinking about DaVita also, you've mentioned previously, is there a number on the overlap of nephrologists that are at some of the mid-DSOs, and then how many of those overlap at DaVita? Again, you mentioned the adoption in this specialty is a little bit more gradual, but these are real differentiators, so curious also on the overlap.

John Butler

Totally agree. You have 20% in the midsize and virtually nothing in the large. The patients aren't different, right? But that's an important question. I'm sure Nick has a sense of that.

John Butler

Yes, when you think about DaVita and how they interact with large group practices around the U.S., they typically are partnering with large group practices in terms of rounding at their clinics, et cetera. And that large group practice also does that with USRC, they do that with IRC, and they do that with Fresenius. And so those physicians who are in those midsize organizations are getting experience with Vafseo. The overlap with DaVita in particular is typically around a third. If you add in Fresenius, it's over 50% overlap in those rounding physicians. And so certainly we hear from physicians who are using the product at USRC or IRC, some frustration about not being able to use it in other places, which bodes well, but importantly, they are getting the experience, so when they do have access to it, we're hoping that has a positive influence around how they treat patients with Vafseo going forward.

John Butler

And I think you made an important point that I didn't really make in the opening remarks, or maybe it probably wasn't as clear as it could be. In the TDAPA world today, there's always a prior auth, if you will, for does the patient have TDAPA reimbursement. Post-TDAPA, while the price is obviously very significantly lower, that exclusion no longer applies, right? I mean, every patient will be able to get it. So even in places where the physicians want to get it but the hoops are too many to jump through, hopefully there are fewer hoops and they can move more quickly. We really count on DaVita kind of driving this at a number of centers, but that doesn't mean that physicians can't access it at other centers. And we would hope that we could start to see an increase. And Nick also referenced Fresenius.

I didn't say anything about that. We met with the Fresenius team, multiple people met with the Fresenius team at ASN as well. I would say they are compelled by the VOICE data also. I don't want to give the impression that we're not doing everything we can to drive business at Fresenius also. And being in dialysis for a number of years, you know that it's kind of dominoes falling. I think as we get DaVita moving more quickly, Fresenius will have to move as well. Our frustration is that we feel like we've been saying that to you for a number of quarters, and we're anxious to see this move also. We feel much more convinced that there's a real desire to move at this point, but in a very deliberate way.

Nabeel Nissar

Thank you for the color. It's very clear clinicians are appreciating the data and look forward to seeing the upcoming quarters. I guess maybe one small question on those missed dialysis sessions, mentioning just kind of the lower compliance. Do we have any data on any impact on hemoglobin control or are those patients more likely to have need for ESA rescue or any thoughts there? And that's my last question. Thank you.

John Butler

We don't really have data on that. If you look at the USRDS data, it suggests that there are generally 13 dialysis sessions in a month if a patient showed up for every session. And the average is about 10.8. We've seen just slightly less than that. I think the expectation, I think most providers feel like they do better and that patients are there more like 12 times. And again, that could be a hospitalization that they're not there for, or they just simply miss it or the like. But it's not 12. It is closer to somewhere between 10.5 and 11. Now if you think about it, Nabeel, if you show up 10 to 11 times and you get your Vafseo every time, you're still talking about 80% plus compliance. That is generally better than what patients have when you send the product home with them. And we usually model something like two-thirds, that they take about two-thirds of their pill. You're still getting more dosing in TIW, with TIW dosing, but it's just less than the expectation, and that drove that inventory shift.

Nabeel Nissar

Great. Thank you for the clarity. Thank you for taking my questions.

John Butler

Thanks so much, Nabeel. I appreciate it.

Operator

And our next question will be coming from the line of Matthew Caufield of H.C. Wainwright & Company.

Matthew Caufield

Hi, John and team. In terms of the noted slower than expected uptake from the major DSOs, specifically, what do you see as the greatest barriers to broader utilization from the large DOs during post-TDAPA into 2027?

John Butler

So, again, I mean, I think if you look at them separately, DaVita is now looking at the product much more seriously and putting a very clear process in place. I think that it's incumbent upon us to make sure that we kind of help educate physicians, do what we can to make sure their experience is a good one. It's different switching someone from Mircera to Vafseo than switching someone from Epogen to Mircera, right? I mean, that has complexity to it. This has more.

So, having seen that, and the great thing about kind of where we are today is DaVita is going to learn a lot from what was experienced at USRC, IRC, and DCI. Dr. Jeff Block is an amazing advocate for this product because he believes in the outcomes benefit for patients. We know that there was a medical directors meeting that they have every year at ASN, where all the medical directors across the dialysis providers meet and Jeff presented the VOICE data to them and took their questions. So I think them understanding, so you understand the benefit, but then you've got to operationalize it. And making sure that operational process goes well is important.

I kind of referenced what we're hearing from USRC, IRC, and DCI is that physicians are doing different things, which is fine, but at the end of the day, you just want to make sure that they're having a good experience. We're feeling confident about DaVita, but again, it's not overnight. They're going to go in a deliberate way through the organization to get an experience level with that. Fresenius is going to take longer, right? They are clearly interested in the data. They got the potential benefit here for their patients, but they are a different organization. They have a relatively new CMO there, they have a brand new CEO there. Organizationally, they're in a little more flux than a place like DaVita. So we're continuing to work there. We have very good relationships with the folks at Fresenius, but I certainly don't want to leave the impression that we're ignoring Fresenius. We are not. We do believe that you don't get the standard of care until they start to move as well. We just know that they're going to take longer to move.

Matthew Caufield

Understood. I appreciate it. Thank you for the color.

John Butler

Thanks, Matt.

Operator

Our next question will be coming from the line of Allison Bradsell of Piper Sandler.

Unknown Speaker

Hi there, this is Peter on for Allison. You recently dosed the first patient in your Phase II basket trial in rare kidney diseases with initial data next year. What initial data can we expect and what findings will be most important in determining the next steps for the program?

Steven Burke

Sure. Hi, it's Steve Burke again. We're principally looking at decrease in urine protein-to-creatinine ratio. We're also measuring complement biomarkers in the blood and urine. We hope to show a substantial reduction in urine protein and do so without an inhibition of the complement system in the blood. And that's a very important differentiator for us versus other complement inhibitors.

John Butler

Yes, let me just kind of underline that. You're going to be looking for impact on proteinuria, and impact on what's the lab test, the alternative pathway in the blood, right? We're impacting the disease at the site, the kidney, without impacting the alternative pathway in the blood. It's pretty straightforward, and hopefully will be quite clear.

Unknown Speaker

Thank you.

Operator

And our next question will be coming from the line of Ed Arce of WestPark Capital.

Antonio Arce

A couple from me. So first on the quarterly results, I think you mentioned it earlier in some of your prepared remarks, but I think I missed it. Just the amount of the underlying growth in the quarter given the discontinuity between the sales and underlying growth. Secondly, you've talked about the potential for Fresenius, but I was curious about the VOCAL results and how you see that fitting in the near term, the impact of those results specifically with CMOs at the various dialysis organizations and ultimately payers and how they would view that data. And then finally, if I could, the reduction in the price that you mentioned, just wanted to get a better sense on the 2 drivers of the lower average dose and the lower compliance. I know you mentioned some of that before, but just wanted to get a better sense for what the changes were relative to what you thought previously. Thanks so much.

John Butler

Thanks, Ed, and welcome back to the call. It's good to have you back. So on the quarterly result, as I mentioned in my remarks, the third quarter underlying demand, patient demand, was somewhere between $19 million and $20 million. So if you think about it, we did just about $15 million in revenue. You took out somewhere between $4 million and $5 million of inventory from the clinics. And we did $21 million-ish last quarter, and it was between $17 million and $18 million demand last quarter. So you can see that was just a shift of inventory from 1 quarter to the next.

Now, the VOCAL results, again, we only have top-line results. I think Steve referenced earlier in his answering the question. There's a lot of really interesting science that I think will make for some interesting additional data. What we always try to do is like, what are the differences? Why is managing anemia with a HIF different than managing anemia with an ESA? And we've shown this outcomes difference. Now, you kind of want to continue to show why, why are you seeing an outcomes difference, because there are these differences in the way that a HIF drug behaves versus an ESA. I think we're in a totality of the data situation, right? And when you're looking at DaVita, it's the outcomes data that's driving them, but they look at every piece of data. And this is just another consistent study where we demonstrated that the drug is able to manage hemoglobin effectively. And you have all these other kind of interesting analyses that may yield some further differentiation. I mean, data has been published that shows differences in lifespan and size of red blood cells. I mean, there's already differences that have been demonstrated in managing with a HIF, but you just want to continue to build that evidence base for why it's a good thing and why it's not a fluke that in 2 studies we've seen this difference in outcome.

Now you mentioned payers. For better or worse, payers aren't really an important market for us to consider because Vafseo is now part of the dialysis bundle. So it is up to the dialysis provider to decide what product and the physicians of course to decide what product they're going to use. The payers don't have much of a say, even when you're outside of Medicare in commercial or Medicaid, these are still generally paid on a bundled rate so payers don't really have much of a say or care much what folks use. And then the reduction in price. I mean, we had seen that ESA prices were starting to drop. I think that's the bigger driver than anything else. Nick, maybe you want to comment on that?

John Butler

Yes, let me start with Epogen. Epogen has been putting pricing pressure into the market over the last, let me call it 18 months. So their prices were coming down. But frankly, DaVita is Mircera, Fresenius is Mircera, IRC is Mircera, and where Epogen is really predominant is within USRC. But frankly, the advocacy within USRC for Vafseo and it being in its TDAPA period, we were somewhat immune to that Epogen pricing decrease. That price continues to drop as they continue to try and gain share through pricing, because at some price point, LDOs view all ESAs as interchangeable. And so you look at that interchangeability, and recently, Mircera has started to reduce their price, and that has a bigger impact. And so when we say we're ESA-like pricing, the DOs are all really good at their jobs and listening to us, and as Mircera comes down, they're also putting pressure on Vafseo price. The other thing that's going on is, as we've kind of said all along, as volume increases, prices come down. And that's what we're seeing here, certainly, this current year.

The important part about all this kind of pricing pieces is in an environment where you're priced similarly and you have data like Vafseo that shows a clear differentiation in hospitalization, which has a large economic impact for the DOs, that becomes a really interesting data point as they think about which products they want to put on protocol and want to really encourage their physician base to use.

John Butler

Yes, I mean, they have this opportunity with these value-based care contracts that reducing hospitalization could yield a huge benefit for them. But the purchasing people just care about the price of acquisition, right? And this is a dialysis, it's just a different market, right? You don't have the same kind of leverage in contracting you do in other markets. And we kind of referenced that the dose was about 10% lower than average. You incorporate that in. It's a little bit more than that when you look at dialysis compliance. But between those, you're probably talking somewhere between a 25% and 30% reduction. And then the Epogen price reduction kind of leads us into that $1,000 to $1,500 price range that we think it's just easier for you all to understand that's where the market is today.

Antonio Arce

Great. Thank you both, John and Nick. Thanks for that. That's helpful, appreciate it.

Steven Burke

Thanks, Ed. Again, welcome back.

Operator

And our next question will come from the line of Roanna Ruiz of Leerink.

Unknown Speaker

Hi, guys. Good morning. This is Anna on for Roanna. Just to dig a little deeper into Ebri, just curious what differences are you looking for in the metrics you mentioned earlier to potentially differentiate between the basket of indications that you're studying? Thanks.

Steven Burke

Sure. Just to reiterate, maybe a little background. Ebri is a fusion protein that recognizes C3d on the surface of cells, and on the back end there are 2 factor H moieties, which are negative regulatory elements in the complement system. So what it's doing is targeting the factor H to the sites of complement activation, and will have a potential to have superior complement inhibition, but without inhibiting the complement system systemically, specifically, as John mentioned, via the alternative pathway, which is measured by a lab assay. So we're looking for excellent reduction in proteinuria across all the conditions. So C3G, that's very important. IgAN, very important. Lupus is a little more complicated because you need to show reduction of proteinuria and stabilization of kidney function, so the estimated GFR. But in all cases, it's reduction of proteinuria, stabilization of the kidney function, without inhibiting the alternative pathway in the blood, because inhibiting that pathway puts you at risk for serious bacterial infections. And so there's a boxed warning for most products and you need to vaccinate the patients. If you can't vaccinate them soon enough, you have to put them on prophylactic antibiotics. So that's the major point of differentiation. Right now we're giving the drug once a week subcutaneously. That may be the frequency going forward, or it could be less frequent. We need to do more work in that regard. So I hope that answers your question.

Unknown Speaker

Yes, super helpful. Thank you.

John Butler

Thanks, Anna.

Operator

I would now like to turn the conference back to John Butler for closing remarks.

John Butler

Thanks, Operator, and thanks all of you for your questions and for joining today. The past few months have provided many opportunities to speak directly with providers, prescribers, trialists, and patient advocates at ASN Kidney Week and other meetings and events. I always walk away feeling optimistic and encouraged that so many people share our commitment to improve the lives of people impacted by kidney disease. A standout among them is Nick Grund. Nick joined Akebia to guide the Vafseo launch and has worked tirelessly to get Vafseo to patients. He navigated the complex TDAPA landscape, built out a sales organization, and prepared the team for our post-TDAPA launch. While he's resigned his position as Chief Commercial Officer, we're fortunate to have Nick on board in a consulting capacity as we work to finalize Vafseo contract extensions into next year and seek to increase adoption, especially at the large dialysis organizations. I want to personally thank him for his dedication to Akebia and our patients. We remain committed to our goal to make Vafseo a standard of care and to advance our kidney disease pipeline. I look forward to updating you all on that progress. Thanks, everyone. Have a great day.

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